Quality Assurance, Post Market Specialist
Core
Support post-market surveillance activities to ensure compliance with U.S. and international regulatory requirements, evaluate product complaints, and maintain patient safety.
Role type
Post-market surveillance specialist (medical devices)
Builds
Regulatory compliance and patient safety reporting for medical device products
Domain
Medical devices / Healthcare regulation
Deliverable
dashboards & analysis
Required skills
Post-market surveillance, regulatory reporting, complaint analysis, CAPA, risk management, technical documentation, cross-functional collaboration
Preferred skills
Medical device industry experience, product development exposure, clinical or nursing background, critical care monitoring, ECG rhythm interpretation
Technologies
Microsoft Office (Word, Excel)
Responsibilities
Review product complaints and adverse event reports, collect patient information from customers, analyze and report adverse event data to regulatory agencies, support Product Field Action and Medical Risk Assessment activities, provide input for nonconformance investigations and audit responses, maintain awareness of evolving global regulations
Seniority
Entry-level to Junior (0-2 years experience)
